Carboplatin

In shortageOrange BookUNIISPLATC L01XA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeL01XA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332317260
1 VIAL in 1 BOX (63323-172-60) / 60 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

BG3F62OND5

CARBOPLATIN

RxCUI 40048

Orange Book

A077266

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Carboplatin Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "BG3F62OND5",
    "rxcui": "40048",
    "inchikey": "OLESAACUTLOWQZ-UHFFFAOYSA-L",
    "display_name": "CARBOPLATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5484d2f0-0cc2-4bba-8f26-c7f6539a9606": {
      "match": "brand_token",
      "title": "CARBOPLATIN INJECTION, SOLUTION [BPI LABS LLC]",
      "spl_version": "5",
      "published_date": "2025-12-29"
    }
  },
  "productid": "63323-172_3a1dd588-13b0-4d58-8d46-3a25a4fc6b40",
  "productndc": "63323-172",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "077266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG/5ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 15, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG/15ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 15, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "450MG/45ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 15, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "600MG/60ML (10MG/ML)",
        "product_no": "004",
        "approval_date": "Feb 15, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBOPLATIN",
  "shortage_reason": "Carboplatin Injection",
  "shortage_status": "current",
  "proprietary_name": "Carboplatin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA077266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBOPLATIN",
  "start_marketing_date": "20091211",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code L01XA02.

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